Treating dysfunctional cardiac tissue

ABSTRACT

Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/894,753 entitled “Treating Dysfunctional Cardiac Tissue,” filed Feb.12, 2018, now U.S. Pat. No. 10,624,744, which is a continuation of U.S.patent application Ser. No. 15/341,945 entitled “Treating DysfunctionalCardiac Tissue,” filed Nov. 2, 2016, now U.S. Pat. No. 9,889,008, whichis a continuation of U.S. patent application Ser. No. 14/636,068entitled “Treating Dysfunctional Cardiac Tissue,” filed Mar. 2, 2015,now U.S. Pat. No. 9,486,206, which is a continuation of U.S. patentapplication Ser. No. 13/949,025 entitled “Treating Dysfunctional CardiacTissue,” filed Jul. 23, 2013, now U.S. Pat. No. 8,968,175, which is acontinuation of U.S. patent application Ser. No. 12/245,040 entitled“Treating Dysfunctional Cardiac Tissue,” filed on Oct. 3, 2008, now U.S.Pat. No. 8,491,455, which claims the benefit of U.S. Provisional PatentApplication No. 60/977,286 entitled “Method and Device for TreatingDysfunctional Cardiac Tissue,” filed on Oct. 3, 2007; and to U.S.Provisional Patent Application No. 61/082,438, entitled “Cardiac AnchorStructures, Methods, and Systems for Treatment of Congestive HeartFailure and Other Conditions,” filed on Jul. 21, 2008, the disclosuresof which are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention is related to improved medical devices, systems,and methods, with many embodiments being particularly useful forreducing the distance between two points in tissue in a minimally orless invasive manner. Specific reference is made to the treatment of afailing heart, particularly the alleviation of congestive heart failureand other progressive heart diseases. The provided devices, systems, andmethods will often be used so as to resize or alter the geometry of aventricle in a failing heart, such as by reducing its radius ofcurvature through the process of excluding a portion of thecircumference from contact with blood, and thereby reduce wall stress onthe heart and improve the heart's pumping performance. Some exemplaryembodiments of the devices, systems, and methods of the presentinvention are directed toward catheter-based, thoracoscopic and/orsubxiphoid techniques used to facilitate sizing of the ventricles.Although specific reference is made to the treatment of a failing heart,embodiments of the present invention can also be used in any applicationin which tissue geometry is altered.

Exemplary embodiments described herein provide implants and methods foralleviating congestive heart failure and other progressive diseases ofthe heart. Congestive heart failure may, for example, be treated usingone or more implants which are selectively positioned relative to afirst wall of the heart (typically an interventricular septum, hereafterknown as the “septum”), and another wall of the heart so as to excludescar tissue and limit a cross sectional area, or distance across aventricle. Functional deterioration of the heart tissues may beinhibited by decreasing a size of the heart chamber and/or approximatingtissues when stress on the tissues is limited. Implant locations andoverall chamber remodeling achieved by placement of a series of implantsmay be determined so as to provide a beneficial volumetric decrease andchamber shape.

Congestive heart failure (sometimes referred to as “CHF” or “heartfailure”) is a condition in which the heart does not pump enough bloodto the body's other organs. Congestive heart failure may in some casesresult from narrowing of the arteries that supply blood to the heartmuscle, high blood pressure, heart valve dysfunction due to degenerativeprocesses or other causes, cardiomyopathy (a primary disease of theheart muscle itself), congenital heart defects, infections of the hearttissues, and the like. However, in most cases congestive heart failuremay be triggered by a heart attack or myocardial infarction. Heartattacks can cause scar tissue that interferes with the heart muscle'shealthy function, and that scar tissue can progressively replace moreand more of the contractile heart tissue. More specifically, thepresence of the scar may lead to a compensatory neuro-hormonal responseby the remaining, non-infarcted myocardium leading to progressivedysfunction and worsening failure.

People with heart failure may have difficulty exerting themselves, oftenbecoming short of breath, tired, and the like. As blood flow out of theheart decreases, pressure within the heart increases. Not only doesoverall body fluid volume increase, but higher intracardiac pressureinhibits blood return to the heart through the vascular system. Theincreased overall volume and higher intracardiac pressures result incongestion in the tissues. Edema or swelling may occur in the legs andankles, as well as other parts of the body. Fluid may also collect inthe lungs, interfering with breathing (especially when lying down).Congestive heart failure may also be associated with a decrease in theability of the kidneys to remove sodium and water, and the fluid buildupmay be sufficient to cause substantial weight gain. With progression ofthe disease, this destructive sequence of events can cause theprogressive deterioration and eventual failure of the remainingfunctional heart muscle.

Treatments for congestive heart failure may involve rest, dietarychanges, and modified daily activities. Various drugs may also be usedto alleviate detrimental effects of congestive heart failure, such as bydilating expanding blood vessels, improving and/or increasing pumping ofthe remaining healthy heart tissue, increasing the elimination of wastefluids, and the like.

Surgical interventions have also been applied for treatment ofcongestive heart failure. If the heart failure is related to an abnormalheart valve, the valve may be surgically replaced or repaired.Techniques also exist for exclusion of the scar and volume reduction ofthe ventricle. These techniques may involve (for example) surgical leftventricular reconstruction, ventricular restoration, the Dor procedure,and the like. If the heart becomes sufficiently damaged, even moredrastic surgery may be considered. For example, a heart transplant maybe the most viable option for some patients. These surgical therapiescan be at least partially effective, but typically involve substantialpatient risk. While people with mild or moderate congestive heartfailure may benefit from these known techniques to alleviate thesymptoms and/or slow the progression of the disease, less traumatic, andtherefore, less risky therapies which significantly improve the heartfunction and extend life of congestive heart failure patients hasremained a goal.

It has recently been proposed that an insert or implant be placed in theheart of patients with congestive heart failure so as to reduceventricular volume. With congestive heart failure, the left ventricleoften dilates or increases in size. This can result in a significantincrease in wall tension and stress. With disease progression, thevolume within the left ventricle gradually increases and blood flowgradually decreases, with scar tissue often taking up a greater andgreater portion of the ventricle wall. By implanting a device whichbrings opposed walls of the ventricle into contact with one another, aportion of the ventricle may be excluded or closed off. By reducing theoverall size of the ventricle, particularly by reducing the portion ofthe functioning ventricle chamber defined by scar tissue, the heartfunction may be significantly increased and the effects of diseaseprogression at least temporarily reversed, halted, and/or slowed.

An exemplary method and implant for closing off a lower portion of aheart ventricle is described in U.S. Pat. No. 6,776,754, the fulldisclosure of which is incorporated herein by reference. A variety ofalternative implant structures and methods have also been proposed fortreatment of the heart. U.S. Pat. No. 6,059,715 is directed to a heartwall tension reduction apparatus. U.S. Pat. No. 6,162,168 also describesa heart wall tension reduction apparatus, while U.S. Pat. No. 6,125,852describes minimally-invasive devices and methods for treatment ofcongestive heart failure, at least some of which involve reshaping anouter wall of the patient's heart so as to reduce the transversedimension of the left ventricle. U.S. Pat. No. 6,616,684 describesendovascular splinting devices and methods, while U.S. Pat. No.6,808,488 describes external stress reduction devices and methods thatmay create a heart wall shape change. Each of these patents is alsoincorporated herein by reference.

While the proposed implants may help surgically remedy the size of theventricle as a treatment of congestive heart failure and appear to offerbenefits for many patients, still further advances would be desirable.In general, it would be desirable to provide improved devices, systems,and methods for treatment of congestive heart failure. It would beparticularly desirable if such devices and techniques could increase theoverall therapeutic benefit for patients in which they are implanted,and/or could increase the number of patients who might benefit fromthese recently proposed therapies. Ideally, at least some embodimentswould include structures and or methods for prophylactic use,potentially altogether avoiding some or all of the deleterious symptomsof congestive heart failure after a patient has a heart attack, butbefore foreseeable disease progression. It would be advantageous ifthese improvements could be provided without overly complicating thedevice implantation procedure or increasing the trauma to the patientundergoing the surgery, ideally limiting patient trauma whilesignificantly enhancing the benefits provided by the implanted device.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide improved medical devices,systems, and methods, in many cases for reducing the distance betweentwo points in tissue, optionally in a less or minimally invasive manner.The present invention may find specific use in the treatment of afailing heart, particularly the alleviation of congestive heart failureand other progressive heart diseases by reconfiguring abnormal heartgeometry that may be contributing to heart dysfunction. In manyembodiments, an anchor is inserted through first and second walls of theheart. An arm of the anchor is deployed and rotationally positionedaccording to a desired contour. Application of tension to the anchor maydraw the first and second walls of the heart into linear contact alongthe desired contour. Additional anchors may be inserted to draw thefirst and second walls of the heart further into contact. By drawing thefirst and second walls of the heart into contact, a dysfunctionalportion of the heart may be closed off along the contour such that theoverall size of a ventricle is reduced and a more beneficial heartgeometry is provided. Heart function may be significantly increased andthe effects of disease progression may be at least temporarily reversed,halted, and/or slowed, with the implanted anchors optionally beingdeployed using catheter-based systems and methods.

In a first aspect, the invention provides a method for treating a heartof a patient. The heart has a chamber bordered by a plurality of walls.A first anchor is inserted along an insertion path through a first wallof the heart. An arm of the first anchor is laterally deployed. The armof the first anchor is rotationally positioned about the insertion pathper a desired contour. First and second walls of the heart are drawninto contact along the desired contour by applying tension to the firstanchor through the insertion path.

In many embodiments, second and third anchors may be inserted throughthe first wall of the tissue along associated insertion paths. The armsof the second and third anchors are laterally deployed. The arms of thesecond and third anchors are rotationally positioned so that applyingtension to the second and third anchors through their associatedinsertion paths extends the contact along the desired contour. Thedesired contour often curves laterally across the first wall.

In some embodiments, a second anchor is inserted through a third wall oftissue along an associated insertion path. An arm of the second anchoris laterally deployed. The arm of the second anchor is rotationallypositioned so that applying tension to the second anchor through theassociated insertion path extends the contact along the desired contour.Hence, the desired contour extends contiguously from the first wall tothe third wall, such as from the septum to an outer wall of the heart.

In many embodiments, a tension member extends along the path from theinserted first anchor. The arm of the first anchor is rotationallypositioned by rotating the anchor with the tension member or a tubularbody over the tension member. An axis of the arm of the first anchor mayextend along an elongate length from a central region adjacent thetension member to an end. Another arm of the first anchor may extendalong an elongate length from the central region to another end so thatthe central region is between the ends, the arms optionally beingdefined by an integral arm structure extending the length of both arms.Tensioning of the tension member optionally forms a fold in the tissuealong the desired contour.

In another aspect, embodiments of the invention provide a method fortreating a heart of a patient. The heart has a chamber bordered by aplurality of walls. A first anchor is inserted along an insertion pathextending through a first wall of the heart. An elongate arm of thefirst anchor is flexed in a first orientation during the insertion ofthe first anchor so as to accommodate a bend in the path. The arm of thefirst anchor is laterally deployed. First and second walls of the heartare drawn into contact by applying tension to the first anchor throughthe insertion path along a second orientation. The arm has a greaterstiffness in the second orientation than in the first orientation so asto inhibit deflection of the arm away from the first wall when suchtension is applied.

Optionally, the bend in the path is defined by a bent flexible catheterbody. Preferably the stiffness of the arm in the second orientation issufficient to induce contiguous contact of the walls along a contourbetween the first anchor and a second anchor when arms of the anchorsare aligned along the contour. In contrast, the stiffness of the arm inthe first orientation need not be sufficient to ensure contiguouscontact of the walls between the anchors.

In another aspect, the invention provides a system for treating a heartof a patient. The system comprises an introducer having a proximal endand a distal end with a shaft therebetween. The distal end is insertablealong an insertion path through first and second heart walls bordering achamber of the heart. A first anchor is axially translatable along thepath of the introducer through the heart walls. An elongate member isextendable proximally from the first anchor and rotationally coupled tothe first anchor so as to axially rotate the first anchor fromproximally of the heart walls. This allows a system user to orient anarm of the anchor along a desired lateral orientation from the insertionpath.

Preferably, the first anchor comprises an arm structure pivotallycoupled to the elongate member so as to pivot from an insertionconfiguration to a deployed configuration. The arm structure in thedeployed configuration may define first and second arms extendable fromthe elongate member along a desired contour, for example, with the firstarm extending along the first orientation and the second arm extendingopposite the first orientation. The first and second arms may compriseintegral portions of the arm structure, and the arm structure in theinsertion configuration may extend along an axis of the elongate memberwith the first arm extending proximally and the second arm extendingdistally, or the like. The elongate member typically comprises a tensionmember extending proximally from an elongate shaft of the first anchor,the elongate shaft pivotally coupled to the arm structure. The elongatemember typically comprises a tension member such as a tether having aplurality of axially repeating features, each of the repeating featurescomprising at least one of a protrusion, bard, or pawl. In someembodiments, the arm structure is connected to the elongate memberthrough a flexible joint.

The system will often include a second or proximal anchor, the secondanchor comprises a locking mechanism operatively engageable with thetension member so as to allow axial movement of the anchors toward eachother, and so as to inhibit axial movement of the anchors away from eachother. The system may include multiple anchor sets, such as by having asecond anchor and a third anchor, each anchor having an associatedelongate member tensionable so as to compress the walls together betweenthe anchor and an associated proximal anchor.

In another aspect, the present invention provides a method for treatinga heart of a patient. The method comprises advancing a distal tip of acatheter into a first ventricle of the heart and making a firstperforation through a septal wall. The distal tip of the catheter isadvanced through the first perforation into a second ventricle, and asecond perforation is made through the wall of the second ventricle. Thedistal tip of the catheter advances through the second perforation intoan epicardial space. An anchor is inserted distally of the wall of thesecond ventricle through a lumen of the catheter, and an arm of theanchor is deployed laterally. The arm is rotated relative to an axis ofthe catheter so that the arm extends along a desired contour, andtension is applied along the insertion path to the anchor so as to urgethe wall of the second ventricle proximally against the septal wallalong the contour.

Optionally, the distal tip of the catheter can be curved by a catheterbending mechanism when the making the first perforation, so that thecatheter within the first ventrical bends away from the septum and backtoward the septum, and/or so that the distal tip faces the septum priorto making the first perforation on the septum. An exemplary bendingmechanism pivotally couples an end of the catheter to a catheter bodyportion proximal of the end using a director. A third perforation can bemade on the on the septal wall adjacent to the first perforation on theseptal wall, a fourth perforation on the wall of the second ventriclecan be made adjacent to the second perforation on the wall of the secondventricle, and so on. A second anchor can be inserted distally of thewall of the second ventricle through the third and fourth perforationsand deployed laterally along a contour extending between the anchors. Byapplying tension along the second insertion path to the second anchor,the wall of the second ventricle can be urged proximally against theseptal wall along the contour. The distal tip of the catheter can bestabilized relative to the septal wall and/or wall of the secondventrical by applying suction through a suction lumen of the catheter.

In another aspect, the invention provides a system for treating a heartof a patient, the heart having a chamber bordered by a plurality ofwalls. The system comprises a tubular body having a lumen extendingalong an axis to a distal end, the tubular body accommodating a bend inthe axis. A first anchor is extendable through a first wall of the heartwithin the lumen, the first anchor having an elongate arm deployablefrom an insertion configuration suitable for insertion of the firstanchor within the lumen to a deployed configuration, the elongate armhaving a first stiffness in a first orientation so as to accommodate thebend in the tubular body, the arm having a second stiffness in a secondorientation, the second stiffness greater than the first orientation soas to inhibit deflection of the arm away from the wall when the arm isdeployed distally of a wall of the heart and proximal tension is appliedto the arm to pull the heart wall proximally.

In yet another aspect, the invention provides an assembly for treating aheart of a patient. The assembly comprises at least two elongate tensionmembers, and at least two distal anchor assemblies. Each distal anchorassembly comprises an elongate arm deployable laterally from the tensionmember after insertion distally through a heart wall, and each distalanchor assembly is coupleable to the distal end of an associate tensionmember so as draw the anchors and a wall of the heart proximally. Aproximal anchor arm system has at least two apertures adapted to beadvanced distally over the tension members and to inhibit proximalmovement of the proximal anchor relative to the tension members whileengaging the heart throughout a contour extending between the tensionmembers.

Optionally, the proximal anchor arm system comprises a first proximalanchor arm having a first adhesive region and an aperture adapted to beadvanced and secured over a first of the tension members. A secondproximal anchor arm similarly has a second adhesive region and anaperture adapted to be advanced and secured over a second tensionmember. The first adhesive region of the first proximal anchor and thesecond adhesive region of the second proximal anchor may adhere to eachother when in contact.

In additional aspects, the invention provides anchor assemblies fortreating a heart of a patient. The assemblies may comprise an expandablemember coupled to a distal end of an elongate shaft. The expandablemember may include a wire which can resiliently expand into a deployed,expanded form, such as a superelastic Nitinol™ shape memory alloy or thelike. In another exemplary anchor assembly the expandable membercomprises a plurality of segments coupled to each other by articulatedhinges, the plurality of segments having a low profile, undeployedconfiguration and a high profile, deployed configuration.

In yet another aspect, the invention provides tether cutting devicescomprising a first elongate shaft having a proximal end, a distal end,and a central lumen. The shaft may comprise a flexible catheter shaft.In some embodiments, at least one cutting member extends outward fromthe distal end of the first elongate shaft, the at least one cuttingmember having an inwardly facing cutting edge. A second elongate shafthas a proximal end and a distal end, and is axially translatable overthe first elongate shaft. The distal end of the second elongate shaftpushes the at least one cutting member inward to cut a tether passedthrough the lumen of the first elongate shaft as the second elongateshaft is advanced distally. In alternative embodiments, a distal cap isaxially translatable over the distal end of an elongate shaft, thedistal cap having an aperture and comprising at least one blade facinginward and disposed on an interior side of the distal cap. The at leastone elongate arm of the elongate shaft pushes the at least one cuttingmember inward to cut a tether passed through the lumen of the elongateshaft as the distal cap is retracted proximally. In still otherembodiments, proximal retraction of at least one elongate member pullsat least one cutting member inward to cut a tether passed through thedistal aperture and central lumen of the elongate tubular shaft, or thelike.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a healthy heart;

FIG. 2 is a cross-sectional view of the heart of FIG. 1;

FIG. 3 is a frontal view of a heart having infarcted tissue;

FIG. 4 is a cross-sectional view of the heart of FIG. 3;

FIG. 5 shows a system according to embodiments of the invention fortreating congestive heart failure;

FIG. 5A shows a magnified view of introducer catheter;

FIG. 6 shows a dilation system;

FIG. 7 shows a cross-section of the dilation system of FIG. 6;

FIG. 8 is a magnified view of the distal end of the dilation system ofFIG. 6 with a balloon of the distal end in an unexpanded configuration;

FIG. 9 is a magnified view of the distal end of the dilation system ofFIG. 6 with the balloon of the distal end in an expanded configuration;

FIGS. 10 and 10A show components of an exemplary anchor assembly;

FIG. 10B shows a side view of the anchor assembly of FIG. 10;

FIG. 10C shows a side cross-sectional view of the anchor assembly ofFIG. 10;

FIG. 10D shows a bottom view of the anchor assembly of FIG. 10;

FIG. 10E shows cross-section of the anchor assembly of FIG. 10;

FIG. 11 shows an exemplary anchor assembly;

FIGS. 11a-11c show the distal end of the anchor device of FIG. 11;

FIG. 11a shows the anchor device in a deployed configuration;

FIG. 11b shows a cutaway view of the anchor device in a deployedconfiguration;

FIG. 11c shows a cutaway view of the anchor device in an undeployedconfiguration.

FIGS. 12a-12c show an introducer catheter having an anchor device placedtherein;

FIG. 12a shows the introducer catheter having the anchor device disposedtherein;

FIG. 12b shows a cutaway view of the introducer catheter;

FIG. 12c shows the introducer catheter with the anchor device moredistally advanced;

FIGS. 13-24 show a method of reducing the distance between two points intissue wall according to embodiments of the invention;

FIG. 25 is a block diagram schematically showing a method of reducingthe distance between two points in tissue wall;

FIG. 26 shows some of the anatomy near a heart treatment site, includingan adult human ribcage;

FIGS. 27-45 show a method of reducing the distance between opposed wallsof a heart according to embodiments of the invention;

FIGS. 45A-45O show exemplary embodiments of external anchors armaccording to embodiments of the invention;

FIGS. 46A-52B show the distal ends of anchor devices according toembodiments of the invention;

FIG. 53 shows a system according to embodiments of the invention fortreating congestive heart failure;

FIGS. 53a-53d show guidewire introducers according to embodiments of theinvention;

FIGS. 54a-54d show an anchor with a retract tether according toembodiments of the invention;

FIGS. 55-66 show a method of reducing the distance between opposed wallsof a heart according to embodiments of the invention;

FIGS. 67-93 show a method of reducing the distance between opposed wallsof a heart using a catheter-based system according to embodiments of theinvention;

FIGS. 94-110 show proximal or external anchor assemblies according toembodiments of the invention;

FIGS. 111-119C show the leading ends of anchor devices according toembodiments of the invention;

FIGS. 120A-122C show exemplary tether cutting mechanisms according toembodiments of the invention;

FIGS. 123A-123D show an exemplary catheter director according toembodiments of the invention;

FIGS. 124A-124E show an exemplary second catheter sheath according toembodiments of the invention;

FIGS. 125A-125C show an exemplary second catheter sheath 12510 accordingto embodiments of the invention; and

FIG. 126 shows a second catheter sheath 12510 comprising a device lumen12625 and a plurality of suction lumens.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally provides improved devices, systems, andmethods for treatment of a heart. Embodiments of the invention may beparticularly beneficial for treatment of congestive heart failure andother disease conditions of the heart. The invention may find uses as aprophylactic treatment, and/or may be included as at least a portion ofa therapeutic intervention.

Embodiments of the invention may find use as a device applied to orimplant placed in the heart of certain patients with congestive heartfailure so as to reduce ventricular volume in a procedure called“Epicardial Catheter-based Ventricular Reconstruction,” or ECVR. Theleft ventricle of hearts affected with congestive heart failure maydilate or increase in size. This increase in size can result in asignificant increase in wall tension and stress. With diseaseprogression, the volume of the left ventricle gradually increases whileforward blood flow gradually decreases. Scar tissue will often take up agreater and greater percentage of the ventricle wall and non-scarred,viable muscle will often dilate as a result of increased strain. Byimplanting a device which brings opposed walls of the ventricle intocontact with one another, a portion of the ventricle, usually thedysfunctional portion, may be constricted or closed off, therebyreducing volume. By reducing the overall size of the ventricle,particularly by reducing the portion of the functioning ventriclechamber formed by scar tissue, the heart function may be significantlyincreased and the effects of disease progression may be at leasttemporarily reversed, halted, and/or slowed.

FIG. 1 shows a normal heart H and FIG. 2 shows the cross-section ofnormal heart H. Normal heart H includes structures such as the aorta AO,pulmonary artery PU, coronary artery CA, apex AP, right ventricle RV,left ventricle LV with a radius 210, and septum SE.

Myocardial infarction and the resultant scar formation is often theindex event in the genesis of congestive heart failure (“CHF”). Thepresence of the scar, if left untreated, may lead to a compensatoryneuro-hormonal response by the remaining, non-infarcted myocardium. FIG.3 shows a region RE (bordered by a dotted line) of left ventricle LVwhich includes scar tissue. With congestive heart failure, the leftventricle often dilates or increases in size as shown in FIG. 4, inwhich radius 210 has increased to a radius 410. This increase in sizecan result in a significant increase in wall tension and stress. Withdisease progression, the volume of the left ventricle LV graduallyincreases while forward blood flow gradually decreases, with scar tissueexpanding while unscarred muscle dilates and becomes thin, losingcontractility. The systems, methods, and devices described herein may beapplied to inhibit, reverse, or avoid this response altogether, oftenhalting the destructive sequence of events which could otherwise causethe eventual failure of the remaining functional heart muscle.

CHF is a condition in which the heart does not pump enough blood to thebody's other organs. CHF may result from narrowing of the arteries thatsupply blood to the heart muscle, for instance, the coronary artery CAas shown in FIGS. 1 and 3. Other causes of CHF include high bloodpressure, heart valve dysfunctions due to degenerative processes orother causes, cardiomyopathy (a disease of the heart muscle itself),congenital heart defects, infections of the heart tissues, and the like.In certain pathological conditions, the ventricles of the heart canbecome ineffective in pumping the blood, causing a back-up of pressurein the vascular system behind the ventricle. The reduced effectivenessof the heart may be due to an enlargement of the heart. For example, theleft ventricular radius 210 of a heart H, as shown in FIGS. 1 and 2, mayeventually increase to a larger left ventricular radius 410 of a failingheart H, as shown in FIGS. 3 and 4.

Acute myocardial infarction (AMI) due to obstruction of a coronaryartery CA is a common initiating event that can lead ultimately to heartfailure. A myocardial ischemia may cause a portion of a myocardium ofthe heart to lose its ability to contract. Prolonged ischemia can leadto infarction of a portion of the myocardium (heart muscle). Once thistissue dies, it no longer acts as a muscle and cannot contribute to thepumping action of the heart. When the heart tissue is no longer pumpingeffectively, that portion of the myocardium is said to be hypokinetic orakinetic, meaning that it is less contractile or acontractile relativeto the uncompromised myocardial tissue. As this situation worsens, thelocal area of compromised myocardium may bulge out as the heartcontracts, further decreasing the hearts ability to move blood forwardand dilating a ventricle. This bulged out myocardium can be seen inregion RE as shown bordered by a dotted line in FIG. 3.

As shown in FIGS. 3 and 4, one problem with a large dilated leftventricle is a significant increase in wall tension and/or stress bothduring diastolic filling and during systolic contraction. In a normalheart, the adaptation of muscle hypertrophy (thickening) and ventriculardilatation maintain a fairly constant wall tension for systoliccontraction. However, in a failing heart, the ongoing dilation isgreater than the hypertrophy and the result is a rising wall tensionrequirement for systolic contraction. This rising wall tensionrequirement may be an ongoing insult to the muscle myocytes (heartmuscle cells), resulting in further muscle damage. In response, theheart tissue often remodels to accommodate the chronically increasedfilling pressures, further increasing the work that the now-compromisedmyocardium must perform. This vicious cycle of cardiac failure mayresult in the symptoms of CHF such as shortness of breath on exertion,edema in the periphery, nocturnal dyspnea (a characteristic shortness ofbreath that occurs at night after going to bed), weight gain, andfatigue, to name a few. The increase in wall stress also occurs duringthroughout the cardiac cycle and inhibits diastolic filling. The stressincrease requires a larger amount of oxygen supply, which can result inexhaustion of the myocardium leading to a reduced cardiac output of theheart.

Embodiments of the present invention may build on known techniques forexclusion of the scar and volume reduction of the ventricle. Unlikeknown techniques that are often accomplished through open surgery,including left ventricular reconstruction, ventricular restoration, theDor procedure, and the like, the treatments described herein will often(though not necessarily always) be implemented in a minimally invasiveor less invasive manner. Embodiments of the invention can provideadvantages similar to those (for example) of surgical reconstruction ofthe ventricle, resulting in improved function due to improved dynamics,and by normalizing the downward cycle initiated by the original injuryand mediated by the neuro-hormonal disease progression response.

Advantageously, the methods, devices, and systems described herein mayallow percutaneous left ventricular scar exclusion and ventricle volumereduction to be applied at any appropriate time during the course of thedisease. Rather than merely awaiting foreseeable disease progression andattempting to alleviate existing cardiac dysfunction, the techniquesdescribed herein may be applied proactively to prevent some or all ofthe heart failure symptoms, as well as to reverse at least a portion ofany existing congestive heart failure effects, to limit or halt theprogression of congestive heart failure, and/or to retard or preventcongestive heart failure disease progression in the future. Someembodiments may, for appropriate patients, limit the impact ofmyocardial infarction scar formation before heart failure even develops.

Referring now to FIG. 5, embodiments of the present invention maycomprise a system 500 for treating congestive heart failure. System 500may comprise a catheter 510, a guidewire 511, a syringe 515, bentinsertion needles or guidewire introducers 520, external anchor arms530, stopcocks 540, Toughy-Borst adapters 550, balloon introducers orintroducer catheters 560, dilation systems or balloon dilators 570,and/or anchor assemblies 580. Catheter 510 will typically comprise anelongate flexible catheter body having a proximal end 510 a, a distalend 510 b, and a central lumen therebetween. The lumen of catheter 510can receive guidewire 511 so that the catheter can be advanced overguidewire 511. In some embodiments, the distal or leading end ofcatheter 510 may comprise a curved end 512. Curved end 512 may beintegral to guidewire 511 or may be a separate element attachable toguidewire 511, with the guidewire optionally being suitable for use inJ-wire access techniques within the heart. Syringe 515 may be adapted tocouple to catheter 510 and infuse catheter 510 with a fluid, forexample, saline and/or a high-contrast imaging fluid, when catheter 510is positioned within a patient's body.

Referring now to FIGS. 5 and 5A, introducer catheter 560 may comprise anelongate catheter body 561 having a proximal end 561P, a distal end561D, a proximal adapter 562, and an expandable member 565 disposed onthe distal or leading end 561D. Introducer catheter 560 can have acentral lumen 1240 and the inner diameter of introducer catheter 560 canbe greater than the outer diameter of a balloon dilator 570 when itsballoon is deflated such that the balloon dilator 570 can fit within thelumen of introducer catheter 560. Balloon dilator 570 may comprise astopcock 540, a Toughy-Borst adapter or valved adapter 550, and aexpandable element or balloon 575 disposed on its distal or leading end.

Referring now to FIGS. 5 and 11-11 c, each anchor assembly 580 maycomprise a tensile member or tether T and a distal or leading end anchor1110. Distal or leading end anchor 1110 may comprise anchor armsextendable laterally from the tether is opposed directions, with theexemplary arms being formed as a single elongate arm body or structureof any medical grade metal or other material, for example, medical gradetitanium. Tensile member or tether T may comprise any biocompatiblepolymer, metal, or other material, for example, metals such as stainlessor nitinol, polyether ether ketone (PEEK), and/or the like. The tether Tmay have a length sufficient to extend proximally out of the patientwhen the anchor is implanted, with the tether optionally being formed bycutting sheet polymer material in a spiral so that the tether is biasedto form a proximal pigtail. External anchor arm 530 and anchor assembly580 may be covered by knotted or woven polyester cloth. Anchor assembly580 may further comprise a plug 1140, and a sheath 1150. Plug 1140 maycomprise chemical or cellular components which facilitate clotting,fibrosis, ingrowth and/or other desirable processes, such as a polyesteror Teflon felt or the like. Similarly, a layer of such materials maycover some or all of the anchor to promote ingrowth, hemostasis, or thelike, optionally by sewing a woven, knit, and/or felt polyester clothover the anchor. The tether T, anchor 1110, and (if it is included) plug1140 may be contained in a lumen of a delivery catheter 1240.

FIG. 5A shows a magnified view of introducer catheter 560. Expandablemember 565 is disposed on the distal or leading end of introducercatheter 560. Introducer catheter 560 comprises valves 562, each coupledto hub 563 through tubings 566. Valves 562 may be used to control fluidintroduction into the lumen of introducer catheter 560 or to controlfluid introduction and removal to either expand or contract expandablemember 565.

A magnified view of balloon dilator 570 is shown in FIG. 6. The distalor leading end tip 610 of balloon dilator 570 is tapered. FIG. 8 shows amagnified view of tapered distal tip 610. As shown in FIG. 8, tapereddistal tip 610 may have a first diameter 810 and a greater, seconddiameter 820 at a location proximal to first diameter 810. FIG. 7 showsa cross-section of balloon dilator 570, which comprises a central lumen710 and a balloon inflation lumen 720. Central lumen 710 can extend froman opening in distal tip 610 to the proximal or trailing end of balloondilator 570 and may extend into Toughy-Borst adapter 550 and/or stopcock540. Balloon inflation lumen 720 may extend from the proximal ortrailing end of balloon dilator 570 to balloon inflation exit port 722which is disposed towards the wider end of tapered distal tip 610. Afluid, for example, saline, may be passed through balloon inflationlumen 720 and balloon inflation lumen port 722 to fill or expand balloon575. Fluid may also be drained from an expanded balloon 575 throughballoon inflation port 722 and balloon inflation lumen 720. FIG. 8 showsballoon 575 in an unexpanded form while FIG. 9 shows balloon 575 in anexpanded form.

FIG. 10 shows an exemplary anchor assembly 581. Anchor assembly 581 maybe generally similar to anchor assembly 580 and may be used in lieu ofanchor assembly 580 for many of the methods and systems describedherein. Anchor assembly 581 comprises a leading or distal anchor armbody 1010. In a deployed form of anchor assembly 581, anchor arm 1010may be generally or roughly perpendicular to elongate member 1020 whichis coupled to tether T or the arm may extend across the tether at someoblique angle. Anchor arm 1010 is coupled to elongate member 1020through joint or hinge 1030. Anchor arm 1010 comprises a distal surface1010 d and a proximal surface 1010 p. In use, anchor arm 1010 is oftenoriented so that proximal surface 1010 p engages with a tissue surface.Anchor arm 1010 can rotate about axis 1030 c which is centered on hinge1030. Anchor arm 1010 may rotate about axis 1030 c by at least about 90°so as to facilitate loading the anchor and tether into a deliverycatheter. The anchor arm may be at least partially covered by (such asbeing largely or entirely encased within) a material that promotestissue ingrowth, such as a woven or felt polyester.

FIG. 11 shows an anchor assembly 580. FIGS. 11a, 11b, and 11c show thedistal or leading end of an anchor assembly 580 and its deliverycatheter 1111 with distal sheath 1150. FIG. 11a shows the distal end ofanchor assembly 580 in a deployed form. FIG. 11b shows the distal end ofanchor assembly 580 in a deployed form. FIG. 11c shows the distal end ofanchor assembly 580 in an undeployed form. The distal end of anchorassembly 580 comprises a distal anchor arm 1110, an elongate member1120, tether T, and a plug 1140. Tether T may comprise a plurality ofrepeating features, for example, protrusions, barbs, or pawls 1130. Inalternative embodiments, tether T may have a slide surface 1177 withoutsuch macroscopic ratchet elements, and which is engageable by a one-wayslide/locking mechanism as described below. Distal anchor arm 1110 isconnected to elongate member 1120 through a joint 1160, which maycomprise a living hinge of flexible, resilient material such that distalanchor arm 1110 can be constrained to be generally parallel to elongatemember 1120. In the undeployed form of anchor assembly 580 as seen inFIG. 11c , distal anchor arm 1110 can be oriented in relation toelongate member 1120 such that distal anchor arm 1110 is able to fitwithin sheath 1150 of delivery catheter 1111. Moving elongate member1120 distally or retracting sheath 1150 proximally can cause distal arm1110 to move out of the constraint of sheath 1150 so that anchorassembly 580 is laterally deployed. In the deployed form, distal anchorarm 1110 can be generally perpendicular or oblique to elongate member1120 and sheath 1150 of delivery catheter 1111 or may otherwise begenerally oriented so as to extend laterally from the tether in aposition relative to elongate member 1120 and sheath 1150 such that itcannot be retracted into sheath 1150 and/or pulled proximally through atissue wall through which the delivery catheter and tether extend.

FIGS. 12a, 12b, and 12c show an anchor assembly 580 within the adapter562 of introducer catheter 560. FIG. 12a shows adapter 562, the proximalor trailing end of introducer catheter 560, and an anchor assembly 580disposed partially within. FIG. 12b shows a cross-section of adapter562. FIG. 12c shows a cross-section of adapter 562 with anchor assembly580 advanced further distally than in FIG. 12b . Adapter 562 includes aproximal expandable member inflation port 1210 and a center lumeninfusion port 1230. Proximal expandable member inflation port 1210 iscoupled to expansion element inflation lumen 1220. Introduction andremoval of fluid through port 1210 and lumen 1220 can respectivelyexpand or contract expansion element 565. Center lumen infusion port1230 is coupled to center lumen 1240 of introducer catheter 560. Fluidmay be introduced to center lumen 1240 through port 1240 to infusecenter lumen 1240.

FIGS. 13-24 show a method of using system 500 to reduce the distancebetween two points in tissue wall. FIG. 13 shows introducer catheter 560with balloon dilator 570 advanced over guidewire 511. Introducercatheter 560 and balloon dilator 570 are distally advanced togetherthrough a perforation 1321 in tissue wall WA in a direction indicated bydistally pointed arrow 1310. The sides of tissue wall WA are in contactwith balloon 575. As shown in FIG. 14, balloon 575 is expanded. As shownin FIG. 14a , the outer diameter of expanded balloon 575 may be at leastas large as (and optionally being larger than) the outer diameter ofintroducer catheter 560 and unexpanded expansion member 565. Forexample, expanded balloon 575 may have a geometry such that, whenexpanded, an outer diameter of balloon 575 and the distal end of thetubular structure at the distal end of balloon introducer 560 taperssmoothly and radially inwardly as the surrounding tissue wall is pushedproximally from over balloon 575 onto balloon introducer 560. An innerchamfer along the lumen at the distal end of balloon introducer 560matching the engaged slope at the proximal end of balloon 575 may helpavoid discontinuities and facilitate distal advancement of the systemthrough the heart wall.

As shown in FIG. 15, introducer catheter 560 is further advanced suchthat expansion member 565 is past or distal of tissue wall WA, and theexpansion member (typically comprising a balloon) is expanded. Guidewire511 has been retracted. As shown in FIG. 16, balloon 575 is contractedor deflated as described above while expansion member 565 is expandedthrough distal expandable member inflation port 1320 which is coupled toexpandable member inflation port 1210. As shown in FIG. 17, balloondilator 570 is proximally retracted as indicated by arrow 1720. Asindicated by proximally pointed arrow 1710, introducer catheter 560 isalso moved proximally such that expansion member 565 is urged againsttissue wall WA. As shown in FIG. 18, balloon dilator 570 has been fullyretracted from center lumen 1240 of introducer catheter 560. As shown inFIG. 19, anchor assembly 580 has been advanced through center lumen 1240of introducer catheter 560. As shown in FIG. 20, once distally advancedfar enough, anchor assembly 580 is deployed. Portions of anchor assembly580 may be radiopaque so that the position and orientation of anchorassembly 580 can be detected and manipulated to a desired orientationwith respect to the long and short axes of the heart. As shown in FIG.21, expansion member 565 is contracted or deflated and introducercatheter 560 is proximally retracted. As shown in FIG. 22, introducercatheter 560 has been fully retracted from tissue wall WA. As shown inFIG. 23, introducer catheter 560 has been fully retracted. Tether T ispulled proximally to apply tension and urge anchor arm 1010 againsttissue wall WA in a proximal direction. Tether T may be rotated torotationally position anchor assembly 580 as desired, for example, tomatch a contour of the heart. Anchor arm 1010 may push plug 1140 to bein contact with the distal end of perforation 1321 in tissue wall WA.Plug 1140 may comprise a compressible plug made of collagen sponge whichmay seal off any potential blood flow. As shown in FIG. 24, tether T maybe advanced through a proximal tissue wall PWA. An external anchor arm530, optionally along with a secondary plug 1140 b, can be placed andsecured through tether T. Proximal retraction of tether T whilemaintenance of external anchor arm 530 urged against the distal end ofproximal tissue wall PWA may apply tension to tether T and reduce thedistance between tissue walls WA and PWA. External anchor arm 530 mayinclude features such as a ratchet which may couple with the repeatingfeatures, such as protrusions, barbs, or pawls 1130, of tether T tomaintain tension and the reduced distance between tissue walls WA andPWA.

FIG. 25 schematically shows an exemplary method 2500 of reducing thedistance between the walls of heart tissue and maintaining the reduceddistance, thereby changing and reconfiguring the geometry of the heart.Method 2500 may change the geometry of the heart by excluding a selectedportion of a ventricle. Method 2500 may be performed endoscopically.Method 2500 comprises steps 2507, 2514, 2521, 2528, 2535, 2542, 2549,2556, 2563, 2570, 2577, 2584, and 2591. Prior to performing the steps ofmethod 2500, a specified location on the outer surface of the heart mayindentified to be the border of a proposed area of the heart to beexcluded may be identified and a desired insertion path may beidentified. A step 2507 places a curved needle, for example, guidewireintroducer 520, between ribs R4 and R5 and through a damaged leftventricle LV wall and septum SE such that the distal tip of curvedneedle is located in the right ventricle RV. The curved needle can makeperforations on specific locations in the left ventricle LV wall andseptum SE wall so that curved needle may be passed through. The curvedneedle may be shaped or otherwise configured so that the perforationsmade on the heart walls are generally perpendicular to the respectivetissue walls. A human rib cage with ribs R4 and R5 are shown in FIG. 26.The curved needle may be placed along an arc-shaped insertion pathparallel or slightly oblique to the plane of the mitral valve, i.e., the“short axis” of the heart to a specified location on the septum SE. Thelength of tissue between the perforation on the left ventricle LV andthe perforation on the septum SE may define the amount of circumferenceof the heart to be excluded. A step 2514 places a guidewire, forexample, guidewire 511, through the curved needle, which may be hollow.Instead of a guidewire, a flexible sheath may be passed over the curvedneedle, for example, if the curved needle is of a solid core type orlacks a lumen. A step 2521 removes or outs the curved needle. If a solidcore type curved needle and a flexible sheath are used, an additionalstep may be required. A guidewire may be threaded through the flexiblesheath such that the tip of the guidewire is contained in the rightventricle, right atrium, pulmonary artery, vena cavae, or otherright-sided vascular structure, with its proximal end protruding throughthe ventricular wall coming out of the proximal end of the flexiblesheath, at which time, the flexible sheath is removed, leaving only theguidewire. A step 2528 places a balloon dilator and expands the balloondilator to a desired diameter. A step 2535 places an introducer, forexample, introducer catheter 560, over the guidewire. A step 2542removes or outs the introducer. A step 2549 places an internal toggleanchor, for example, anchor 580, through the introducer and sets it inposition on the right ventricular RV side of the septum SE. The internaltoggle anchor may be rotated to a desired orientation. A step 2556removes or outs the introducer. A step 2563 places an external anchorarm, for example, external anchor arm 530, over the lead of an internalguidewire of the internal anchor to the exterior wall of the leftventricle LV. A step 2570 deploys additional internal toggle anchors,for example, using at least some of the previously discussed stepsincluding steps 2507, 2514, 2521, 2528, 2535, 2542, 2549, 2556, and2563. A step 2577 deploys additional external anchor arms to theexternal wall of the left ventricle LV. A step 2584 alternately cinchesand/or tightens the anchors, for example, to selectively reduce thedistance between the septum and the left ventricle LV so that thegeometry of heart H may be changed as desired. A step 2591 trims theanchor leads.

FIGS. 27-45 show an exemplary method of changing the geometry of theheart with a system 500 according to embodiments of the presentinvention. The method shown by FIG. 27-45 may be generally similar tomethod 2500 and may optionally be performed endoscopically,percutaneously, or otherwise in a less invasive manner. The heart may beaccessed through, for example, a small incision made between the ribs ora thoracotomy. As shown in FIG. 27, a bent insertion needle or guidewireintroducer 520 is passed through a desired insertion path through theleft ventricle LV wall and through septum SE into the right ventricleRV. Guidewire introducer 520 may be configured so that the perforationsmade by guidewire introducer 520 on the left ventricular wall and theseptum wall are perpendicular to their respective walls. As shown inFIG. 28, a guidewire 511 is placed through the lumen of guidewireintroducer 520 so that guidewire 511 threads through the outer leftventricle LV wall, through the septum SE, and into the right ventricleRV. As shown in FIG. 29, guidewire introducer 520 has been removed. Asshown in FIG. 30, introducer catheter 560 and balloon dilator 570 areadvanced over guidewire 511 to contact the heart H. Balloon 575 is incontact with a perforation in the left ventricle LV wall. As shown inFIG. 31, balloon 570 is expanded to dilate the left ventricle LV wall.As shown in FIGS. 32 and 33, introducer catheter 560 and balloon dilator570 are further advanced into the heart. As shown in FIG. 33, balloon575 is deflated. As shown in FIG. 34, balloon introducer catheter 560and balloon dilator 570 are further advanced. Balloon 575 contacts aperforation in the septum SE wall. As shown in FIG. 35, balloon 575 isexpanded to dilate the septum SE wall. As shown in FIG. 36, introducercatheter 560 and balloon dilator 570 are further advanced through theseptum SE wall. Balloon 575 is deflated. As shown in FIG. 37, expansionmember 565 is expanded. As shown in FIG. 38, introducer catheter 560 ispulled proximally so that expanded expansion member 565 urges againstthe septum SE wall. As shown in FIG. 39, balloon dilator 570 is removedfrom center lumen 1240 of balloon introducer 560. As shown in FIG. 40,guidewire 511 is removed and anchor assembly 580 is advanced, forexample, through the use of a pushrod, through center lumen 1240 ofballoon introducer 560. The distal end of anchor assembly 580, which wasparallel to tether T, exits balloon introducer 560 and is rotated sothat it is generally perpendicular to tether T, i.e., anchor assembly580 is laterally deployed into right ventricle RV. Anchor assembly 580may be rotated via tether T to align or position anchor arm 1110 along acontour as desired. As shown in FIG. 41, expansion member 565 iscontracted or deflated and balloon introducer 560 is removed. Anchorassembly 580 is pulled proximally so that arm 1110 urges against theseptum SE wall. As shown in FIG. 42, an external anchor arm 530 isplaced over tether T of anchor assembly 580, leaving a central region4210 of tether T in the left ventricle. The steps shown in FIGS. 27-42can be repeated one or more times for different, adjacent locations ofthe heart H, for example, as shown in FIG. 43. Arms 1110 are rotated togenerally extend along the contour or line connecting the perforationsites. Tethers T can be pulled proximally to apply tension whileexternal anchor arms 530 are advanced distally, thus reducing the lengthof central region 4210 and drawing the walls of the left ventricle LVand the septum SE together. External anchor arms 530 may comprisefeatures such as a ratchet which may couple with the repeating features,protrusions, barbs, or pawls 1130 of tether T thus maintaining thereduced central region 4210. As shown in FIG. 45, tethers T are trimmed.Depending on the number and locations of anchor assemblies 580 andanchor arm pairs comprising anchor arms 1110 and external anchor arms530 and also the amount of tension applied to anchor assemblies 580, thewalls of the left ventricle LV and septum SE may be shaped into adesired contour.

The result of the deployed anchor assemblies 580 with anchor arm pairsof anchor arms 1110 and external anchor arms 530 may be a solid,continuous line, contour, or wall of approximation of two adjacent heartwalls that will partition and clearly define a portion of the heartwhich remains in contact with the blood and another portion of the heartthat will be excluded from continuity with the chamber. A line orcontour of apposition can be formed. The excluded portion may be treatedby insertion, injection, or otherwise treating the cavity of theexcluded portion to form a clot or fibrosis. For example, scleroticsubstances, coils, tissue glues, and the like may be injected in thecavity of the excluded portion. Specific residual fistulae betweenexcluded and included portions of the left ventricular LV chamber maylikewise be treated. Single or multiple pairings of anchor assemblies580 and external anchor arms 530 may be added on the included portion ofthe line of apposition to increase the magnitude of volume and radiusreduction. Migration of anchor positions can be fixed in place in theheart H by a perforating tensile member attached to a middle internalanchor and passed through a customized through-and-through aperture inthe external anchor arm, allowing adjustable inter-anchor distancebetween the anchor a pairing of anchor assembly 580 and external anchorarm 530.

FIGS. 45A-45G show an exemplary external anchor arm 4500 with externalhere encompassing outside the chambers of the heart or in thepericardial space. External anchor arm 4500 may be similar to and can beused in a substantially similar manner as external anchor arm 530. FIG.45A shows a side view of external anchor arm 4500. FIG. 45B shows a topview of external anchor arm 4500. FIGS. 45C and 45D both showcross-sectional views of external anchor arm 4500. External anchor arm4500 defines a channel or aperture 4510 through which tether T may bethreaded through. External anchor arm 4500 comprises a space 4520 a anda space 4520 b. External anchor arm 4500 may have asymmetrically roundedleading ends. When tether T is threaded through aperture 4510, externalanchor arm 4500 may be rotated such that space 4520 a and space 4520 baccommodate tether T as shown in FIGS. 45E and 45F. This accommodationcan allow external anchor arm 4500 to be advanced over tether T whenboth tether T and external anchor arm 4500 are within a sheath or atube.

It may be advantageous to include a locking mechanism such that whenactivated, external anchor arm 4500 is fixed in place relative to anchor580. The locking mechanism can fix external anchor arm 4500 to thetether T and may be reversible and removable. The locking mechanism maycomprise friction devices, ratchets, cam-devices, and the like and maybe built into or onto external anchor arm 4500. The locking mechanismmay be disposed nearby or within channel 4510 and may be orientedtowards the interior of channel 4510. For example, the locking mechanismmay comprise locking element 4530 comprising a wedge 4535. Tether T canbe threaded through locking element 4530. As seen in FIG. 45G, wedge4535 may occupy a space in external anchor arm 4500 when external anchorarm 4500 is perpendicular to tether T. In certain embodiments, lockingelement 4530 is placed proximal of external anchor arm 4500 and isadvanced along with external anchor arm 4500 over tether T. Wedge 4535and/or the asymmetrically rounded leading edge of external anchor arm4500 may initiate rotation of external anchor arm 4500 when externalanchor arm 4500 exits a sheath or tube and encounters resistance tofurther advancement, for example, as when tissue is contacted.

FIGS. 45Gi-45J show an exemplary external anchor arm assembly 4502. FIG.45Gi shows a side view of external anchor arm assembly 4502. FIG. 45Hshows a bottom or proximal view of external anchor assembly 4502. FIG.45I shows a profile of external anchor assembly 4502. FIG. 45J shows aperspective view of external anchor assembly 4502. External anchor armassembly may be used in a similar manner as external anchor arm 530 andexternal anchor arm 4500 described above. External anchor arm assembly4502 comprises an external anchor arm base 4507 with a proximal surface4507 p and a distal surface 4507 d. In use, external anchor arm assembly4502 can be oriented so that proximal surface 4507 p faces the proximaldirection and distal surface 4507 d faces the distal direction. Externalanchor assembly 4502 comprises a locking or friction mechanism 4531.Friction mechanism comprises a friction imposing surface 4532 coupled toan elastic band or resilient spring wire 4537. Spring 4537 is held byrings 4539. External anchor arm assembly 4502 may comprise a rectangularchannel 4512. When tether T is threaded through rectangular channel4512, spring 4537 may urge friction imposing surface 4531 against tetherT once the tether has been tensioned. More specifically, the orientationof engagement between the friction imposing surface 4532 and pivotalmovement of the friction imposing surface 4532 away from the tether Twhen the tether T is pulled proximally through the proximal anchor so asto bring the walls toward each other allows sliding movement in onedirection. In contrast, the friction imposing surface 4532 pivotscam-like toward the engaged surface of the tether T when the tether T ispulled distally (for example, when the anchors are pulled away from eachother) and may lock external anchor arm base 4507 in place relative totether T.

FIGS. 45K-45O show an other exemplary external anchor arm 4550. Externalanchor arm 4550 may share similar features with and may be used in asimilar manner as external anchor arms 530, 4500, and 4502 describedabove. FIG. 45K-45N each show a view of external anchor arm 4550 with atether T threaded through a channel 4551. FIG. 45K shows a top view,FIG. 45L shows a perspective view, FIG. 45M shows a top side view, FIG.45N shows a bottom side view, and FIG. 45O shows a front view. Externalanchor arm 4550 comprises a distal end 4553, a roundly tapered distalportion 4553T, a proximal end 4556, a roundly tapered proximal portion4556T, a first narrow side 4562 with a distal opening 4562C, a secondnarrow side 4565 with a proximal opening 4565C, a first wide side 4568,and a second wide side 4571. When Tether T is threaded through channel4551, first narrow side 4562, second narrow side 4565, first wide side4568, and second wide side 4571 form a rectangular box around tether T.First wide side 4568 and second wide side 4571 fully cover tether T.First narrow side 4562 and second narrow side 4565 cover tether Tpartially. Distal opening 4562C of first narrow side 4562 and proximalopening 4565C of second narrow side 4565 do not cover tether T. Distalopening 4562C is directly opposite a solid proximal portion of secondnarrow side 4565. Likewise, proximal opening 4565C is directly oppositea solid distal portion of first narrow side 4562. There is a degree ofoverlap between distal opening 4562C and proximal opening 4565C. Theheight and width of this overlap will often be equal to that of thecross-section of tether T. As external anchor arm 4550 is advanceddistally over tether T and eventually into contact with an external wallof a heart, further distal advancement of external anchor arm 4550 willcause external anchor arm 4550 to rotate. This rotation is due aredirection of force by the shape of roundly tapered distal portion4553T and the accommodation of tether T by openings 4562C and 4565C.Because of wide sides 4568 and 4571 fully cover tether T and openings4562C and 4565C are specifically sized and oriented as described above,external anchor arm 4550 is only allowed to rotate no more than 90° inone direction. Once external anchor arm 4550 has contacted the externalwall of the heart and has rotated approximately 90° to be parallel tothe external wall of the heart, narrow side 4562 is in intimate contactwith the external wall of the heart. External anchor arm 4550 may thenbe fixed onto tether T with a lock mechanism. A lock mechanism may bebuilt into external anchor arm 4550 or may comprise an external lockingelement such as locking element 4530.

FIGS. 46A, 46B, 47A, 47B, 48A, 48B, 49A, 49B, 50A, 50B, 51A, 51B, and 52schematically show alternative exemplary embodiments of the distal armof an anchor according to embodiments of the invention, for example, foruse as anchor 580.

FIGS. 46A and 46B show leading end 4600. Leading end 4600 is generallysimilar to the distal or leading ends of anchor 580 as described above.Leading end 4600 comprises an elongate shaft 4610 coupled to a distalarm 4620 through a joint or flexible region 4630. In the undeployed formof leading end 4600 as shown in FIG. 46A, arm 4620 can be turned on itsside so both arm 4620 and elongate shaft 4610 can fit within sheath1150. As shown in FIG. 46B, when no longer constrained by sheath 1150,arm 4620 resiliently returns to its deployed form in which arm 4620 isgenerally perpendicular to elongate shaft 4610.

FIGS. 47A and 47B show leading end 4700. Leading end 4710 comprises anelongate shaft 4710 coupled to a distal arm 4720 through a joint orflexible region 4630. In the undeployed from of leading end 4700 asshown in FIG. 47A, arm 4720 can be folded in half so that both arm 4720and elongate shaft 4710 can fit within sheath 1150. As shown in FIG.47B, when no longer constrained by sheath 1150, arm 4720 resilientlyreturns to its deployed form in which arm 4720 is generallyperpendicular to elongate shaft 4710.

FIGS. 48A and 48B show leading end 4800. Leading end 4800 comprises anelongate shaft 4810 coupled to a distal arm 4820 through a joint orflexible region 4830. Distal arm 4820 can further comprise side arms4840 which are disposed on the ends of distal arm 4840 and are generallyperpendicular to both elongate shaft 4810 and distal arm 4820. As shownin FIG. 48B, side arms 4840 extend from opposite sides and opposite endsof distal arm 4820. In the undeployed form of leading end 4900 as shownin FIG. 48A, arm 4820 can be turned on its side and side arms 4840tucked within arm 4820 so that arm 4820, side arms 4840, and elongateshaft 4610 can fit within sheath 1150. As shown in FIG. 46B, when nolonger constrained by sheath 1150, arm 4820 along with side arms 4840resiliently return to its deployed form in which arm 4820 is generallyperpendicular to elongate shaft 4810.

FIGS. 49A and 49B show leading end 4900. Leading end 4900 comprises anelongate shaft 4910 coupled to a distal arm 4920 through a joint orflexible region 4930. Distal arm 4920 can further comprise an inner arm4940 which can be disposed within distal arm 4920 and is generallyperpendicular to both elongate shaft 4910 and distal arm 4920 whenleading end 4900 is laterally deployed. As shown in FIG. 49B, side arms4940 extend from opposite sides and opposite ends of distal arm 4920. Inthe undeployed form of leading end 4900 as shown in FIG. 49A, arm 4920can be turned on its side and inner arm 4940 tucked within arm 4920 sothat arm 4820, inner arms 4940, and elongate shaft 4910 can fit withinsheath 1150. As shown in FIG. 46B, when no longer constrained by sheath1150, arm 4920 along with inner arm 4940 resiliently return to itsdeployed form in which arm 4920 is generally perpendicular to elongateshaft 4910.

FIGS. 50A and 50B show leading end 5000. Leading end 5000 comprises anelongate shaft 5010 coupled to a distal arm 5020 through a joint orflexible region 5030. Distal arm 5020 can further comprise side arms5040 which are disposed on the ends of distal arm 5040 and are generallyperpendicular to both elongate shaft 5010 and distal arm 5020. As shownin FIG. 50B, side arms 5040 extend from opposite ends of distal arm5020. The ends of side arms 5040 are connected to each other by bands5060. In the undeployed form of leading end 5000 as shown in FIG. 50A,arm 5020 can be turned on its side and side arms 5040 can be tuckedwithin arm 5020 so that arm 5020, side arms 5040, and elongate shaft5010 can fit within sheath 1150. As shown in FIG. 50B, when no longerconstrained by sheath 1150, arm 5020 along with side arms 5040resiliently return to its deployed form in which arm 5020 is generallyperpendicular to elongate shaft 5010 and side arms 5040 are generallyperpendicular to both arm 5020 and shaft 5010.

FIGS. 51A and 51B show leading end 5100. Leading end 5100 is generallysimilar to leading end 4900 described above with reference to FIGS. 49Aand 49B. Leading end 5100 further comprises bands 5110 which connect theends of side arm 4940 to the ends of distal arm 4920.

FIG. 52 shows selected components of a distal end 5200 of an alternativeanchor assembly. Distal end 5200 comprises a distal anchor arm body5210. Distal arm 5210 comprises a plurality of repeating elements 5211which are formed by a plurality of distally facing cuts 5211 a.Repeating elements 5211 can allow the opposed distal arms of body 5210to flex proximally, while engagement between the repeating elementsinhibits flexing of the arms distally. Opposite ends of distal arm 5210include protrusions 5212 which can allow distal arm 5210 to couple withsecondary distal arm 5216 through apertures 5218 located on oppositeends of secondary distal arm 5216, the secondary arm thereby forming aproximal beam web to further inhibit distal flexing of the anchor. Theapertures 5218 may be laterally longer than protrusions 5212 so as toaccommodate proximal flexing of the distal arm body 5210. Distal arm5210 is connected to elongate shaft 5220 through a living hinge 5215.Elongate shaft 5220 is coupled to tether T. Tether T comprises aplurality of repeating members 5240. Repeating members 5240 comprise aseries of apertures or slots. External anchor arm 5230, which can bethreaded over tether T, may comprise a plurality of repeating features,protrusions, barbs, or pawls which may fit into at least one ofrepeating feature 5240, thereby locking external anchor arm 5230 inplace relative to tether T and anchor 5210. Anchor structures similar tothat of FIG. 52 are seen in FIGS. 52A and 52B.

It should be appreciated that systems for treating congestive heartfailure according to embodiments of the invention may comprise differentcombinations of different components or elements. For example, FIG. 53shows a system 5300 for treating congestive heart failure. System 5300may share many of the same components or elements as system 500, forexample, introducer catheter 510, guidewire 511, syringe 515, externalanchor arms 530, balloon introducer 560, balloon dilator 570, andanchors 580. System 5300 may further comprise a placement scale 597, apush rod 595, dilation members 590, a straight hollow bore insertionneedle or guidewire introducer 521, a curved hollow bore insertionneedle or guidewire introducer 523 a, a curved hollow bore insertionneedle or guidewire introducer 523 b, and a curved hollow bore insertionneedle or guidewire introducer 523 c. A dilation member 590 has atapered distal end and can be sized so that it can be axially translatedwithin a central lumen of balloon introducer 560. The tapered distal endof dilation member 590 may dilate a perforation in a wall of a heart asdilation member 590 is advanced such that a balloon introducer 560 canbe threaded through the perforation. In some cases, only dilationmembers 590 are used to dilate a perforation in a heart wall and the useof a balloon 575 on the distal end of balloon dilator 570 to expand ordilate a perforation in the heart wall may not be necessary.

FIGS. 53a, 53b, 53c, and 53d a show straight hollow bore insertionneedle 521, a first curved hollow bore insertion needle 523 a, a secondcurved hollow bore insertion needle 523 b, and a third curved hollowbore insertion needle 523, respectively. Straight hollow bore insertionneedle 521 has a sharp distal tip 522. Curved hollow bore insertionneedle 523 a has a sharp distal tip 525 a which is aligned with an axis524 a of proximal straight portion 526 a. A distal portion of insertionof insertion needle 523 a is curved. The radius of curvature of thecurved distal portion may be selected such that when insertion needle523 a is inserted into the heart at a first specified point, sharpdistal tip 525 a perforates the left ventricular wall at a roughly rightangle and also perforates the septal wall at a roughly right angle at asecond specified point as insertion needle 523 a is further advanced,with the first and second perforation points being separated by adistance in a first desired range. Curved hollow bore insertion needle523 b has a sharp distal tip 523 b which is aligned with axis 524 b,which is the central axis of proximal straight portion 526 d. A distalportion of insertion of insertion needle 523 b is curved. The radius ofcurvature of the curved distal portion may be selected such that adifferent range of separation distances between the perforation pointscan be provided, such that when insertion needle 523 b is inserted intothe heart at a specified point, sharp distal tip 525 b perforates theleft ventricular wall at a roughly right angle and later perforates theseptal wall at a roughly right angle as insertion needle 523 b isfurther advanced. Curved hollow bore insertion needle 523 c has a sharpdistal tip 523 c which is aligned with axis 524 c, which is the centralaxis of proximal straight portion 526 c. A distal portion of insertionof insertion needle 523 c is curved so as to accommodate a third rangeof separation distances. The radius of curvature of the curved distalportion may be selected such that when insertion needle 523 c isinserted into the heart at a specified point, sharp distal tip 525 cperforates the left ventricular wall at a roughly right angle and laterperforates the septal wall at a roughly right angle as insertion needle523 b is further advanced. The first, second, and third ranges allowreshaping (particular radius reduction) along the axis of the ventricleto be varied so as to provide a desired overall ventricle geometry, ascan be further understood with reference to application Ser. No.11/751,573, the full disclosure of which is incorporated herein byreference. Typical separation differences between perforation points maybe pi times the difference in diameter between that of a dysfunctionalheart and the same heart after a desired ventricular volume reduction.Exemplary differences in diameter range from about ½ to about 3 cm,resulting in differences in diameter from about 1.5 to about 10 cm,preferably about 4 cm to about 6 cm.

FIGS. 54a, 54b, and 54c show the distal or leading end of an anchorassembly 580. As shown in FIG. 54a , sheath 1150 can restrain anchor arm1110. As shown in FIG. 54b , sheath 1150 may be retracted to exposeanchor arm 1110. As described above, once anchor arm 1110 is free fromthe restraint of sheath 1150, anchor arm 1110 is free to be deployed asshown in FIG. 54c . In the deployed configuration, anchor arm 1110 isgenerally oblique or perpendicular to elongate member 1120. As shown inFIGS. 54b and 54c , anchor assembly 580 may further comprise a leash5410 coupled to anchor arm 1110 and which can move anchor arm 1110 backto an undeployed configuration, i.e., generally parallel to elongatemember 1120, after anchor arm 1110 has been deployed.

Referring now to FIG. 54d , optionally an inner tube 5412 may beadvanced through introducer 560 (or another tubular delivery or accessstructure) to aid in retraction of the anchor. Leash 5410 can then pullarm 1110 inward toward an inner lumen of inner tube 5412. Even if theextreme end of arm 110 catches on the distal end of inner tube 5412, theinner tube and anchor can be safely retracted proximally togetherthrough the lumen of introducer 560.

It should also be appreciated that systems for treating congestive heartfailure according to embodiments of the invention may be used formethods which comprise different combinations and/or orders of differentsteps. FIGS. 55-66 show a method of using system 5300 to reduce thedistance between two points in tissue wall. Method 5300 may be generallysimilar to method 2500 and method 500 described above. As shown in FIG.55, curved hollow bore insertion needle or guidewire introducer 523 a isthreaded through the wall of left ventricle LV and septum SE such thatthe distal tip of needle 523 a is in contact with the interior of theright ventricle RV. The distal tip 523 t of needle 523 a aligns withaxis 524 of needle 523 a so that the surgeon performing the method canuse sight to properly orient needle 523 a so the perforations made onthe wall of left ventricle LV and septum SE are properly aligned. Asshown in FIG. 56, guidewire 511 is threaded through the hollow center ofcurved hollow bore needle 523 a into at least the right ventricle RV. Asshown in FIG. 57, needle 523 a has been removed, leaving guidewire 511in place. As shown in FIG. 58, balloon introducer 560 is guided byguidewire 511 and is placed against the outer wall of left ventricle LV.Dilation member 590 is within balloon introducer 560. The distal end 590t of dilation member 590 is tapered. As balloon introducer 560 anddilation member 590 are advanced, the tapered end 590 t dilates orexpands the perforation made on the wall of the left ventricle LV.Dilation member 590 may be rotated to facilitate dilation of the tissuewall perforation. As shown in FIG. 59, balloon introducer 560 anddilation member 590 are further advanced. Dilation member 590 dilates orexpands the perforation made of the wall of the septum SE. As shown inFIG. 60, balloon introducer 560 has been advanced so that expansionmember 565 is within the right ventricle RV. Balloon introducer 560 ispulled proximally so that expansion member 565 urges against the wall ofthe septum SE. Dilation member 590 has been retracted and removed. Inplace of dilation member 590 is anchor assembly 580. Expansion member565 is expanded. As shown in FIG. 61, anchor assembly 580 has beenadvanced and deployed in right ventricle RV. As shown in FIG. 62,expansion member 565 has been contracted or deflated and balloonintroducer 560 has been proximally retracted. As shown in FIG. 63,tether T of anchor assembly 580 is pulled proximally so that arm 1110urges against the wall of septum SE. As shown in FIG. 64, externalanchor arm 590 is advanced over tether T. The steps described withreference to FIGS. 55-64 can be repeated, preferable at different,adjacent locations on heart H and with different guidewire introducers,for example, with any of curved hollow bore insertion needle 523 b,curved hollow bore insertion needle 523 c, and straight hollow insertionbore needle 521. As shown in FIG. 65, tether T and anchor assembly 560have been pulled proximally while external anchor arm 590 is maintainedin position, thereby reducing the distance between the walls of rightventricle RV and the septum SE and reconfiguring the geometry of theheart. In the cases in which multiple anchor pairs are used, the stepdescribed with reference to FIG. 65 can be performed after all of thesteps described with reference to FIG. 55-64 have been performed foreach of the anchor pairs, resulting in a heart H with reconfiguredgeometry as shown in FIG. 66. FIG. 66 also shows how alignment of anchorarms along a contour 661 can provide sealing of a portion of a ventricaland a beneficial remodeled chamber geometry.

It should be appreciated that the specific steps illustrated in FIG. 25,in FIGS. 27-45, and in FIGS. 55-66 provide particular methods ofchanging the geometry of a heart, according to embodiments of theinvention. Other sequences of steps may also be performed according toalternative embodiments. For example, alternative embodiments of theinvention may perform the steps outlined above in a different order.Moreover, the individual steps illustrated in FIG. 25, in FIGS. 27-45,and in FIGS. 55-66 may include multiple sub-steps that may be performedin various sequences as appropriate to the individual step. Furthermore,additional steps may be added or removed depending on the particularapplications. One of ordinary skill in the art would recognize manyvariations, modifications, and alternatives.

Embodiments of the invention also provide systems, device and methods bywhich the geometry of the heart is changed through a percutaneouslyperformed procedure, which may be referred to as “percutaneousventricular reduction” or PVR. FIGS. 67 to 93 show an exemplary PVRprocedure using a catheter based system according to embodiments of theinvention. As shown in FIG. 67, the femoral vein FV may be accessed forPVR procedures. An incision is made to access the femoral vein FV and ahemostasis valve 6720 is placed on the incision. A first catheter sheath6710 is advanced through hemostasis valve 6720 and into the femoral veinFV. Alternatively, a PVR procedure may involve accessing the internaljugular vein in the neck.

FIGS. 68 and 69 show first introducer or catheter sheath 6710 furtheradvanced toward heart H, through the inferior vena cava IVC, rightatrium RA, tricuspid valve TV, and into the right ventricle RV. FIG. 68shows a perspective view of the heart H with catheter sheath 6710advanced therein. FIG. 69 shows a cutaway perspective view of the heartH with catheter sheath 6710 advanced therein. As seen in FIG. 69,catheter sheath 6710 may be advanced adjacent to an unhealthy ordysfunctional area 6910 of the septum SE.

FIG. 70 shows a cutaway perspective view of heart H. A second introduceror catheter sheath 7010 is advanced through the lumen of first cathetersheath 6710. The distal portion 7015 of second catheter sheath 7010 hasa curve, for example, a 90° curve, and is positioned so that it facesthe dysfunctional area 6910 of the septum SE.

FIG. 71 shows a transverse cross-sectional or four-chamber view of heartH. A guidewire 7110 and a dilator 7120 are advanced through secondcatheter sheath 7010. Guidewire 7110 is used to perforate the septum SE,preferably the dysfunctional area 6910 of the septum SE, for example, byusing radiofrequency (RF) energy. Guidewire 7110 is then advanced andcoiled in the left ventricle LV. Dilator 7120 has a tapered distal end7125.

FIG. 72 shows a short axis cross-sectional view of the heart H, showingthe left atrium LA, the mitral valve MV, the left ventricle LV, theseptum SE, the right ventricle RV, the tricuspid valve TV, and the rightatrium RA. FIG. 72 shows how first catheter sheath 6710, second cathetersheath 7010, dilator 7015, and tapered distal end 7125 may be positionedto guide guidewire 7110 through the dysfunctional area 6910 of theseptum SE.

FIG. 73 shows a cross-sectional view of the heart H with dilator 7120advanced through the septum SE and into the left ventricle LV throughthe perforation made by guidewire 7110.

FIG. 74 shows a cross-sectional view of the heart H as dilator 7120 isadvanced through the anterior wall of the left ventricle LV. FIGS. 75and 76 shows a magnified view of distal end 7125 as dilator 7120 isadvanced through the anterior wall of the left ventricle LV. Guidewire7111 has a distal tip. Guidewire 7110 is used to perforate the anteriorwall of the left ventricle LV, for example, by using radiofrequency (RF)energy. As shown in FIG. 76, after dilator 7110 has advanced through theanterior wall of the left ventricle LV, second catheter sheath 7010 isadvanced through the anterior wall AW of left ventricle LV.

FIG. 77 shows a cross-sectional view of the heart H as guidewire 7110and dilator 7120 are retrieved, leaving second catheter sheath 7010through the anterior wall AW of the left ventricle LV. FIG. 78 shows ananchor assembly 580 loaded onto the proximal end of the second cathetersheath 7010. Anchor assembly 580 is then pushed to the distal end of thesecond catheter sheath 7010.

FIG. 79 shows a cross-sectional view of the heart H as anchor 580 isdelivered to the epicardium of the anterior wall of left ventricle LV.As shown in FIG. 80, anchor assembly 580 is then aligned along the longaxis of the heart. As shown in FIG. 81, a hemostatic plug 1140 can bedelivered through the second catheter sheath 7010 over tether 10 againstdistal anchor arm body 1110 of anchor assembly 580. As shown in FIGS. 82and 83, tension can then be applied to tether T to position distalanchor arm body 1110 against the epicardium.

FIG. 84 shows a cross-sectional view of the heart H as second cathetersheath 7010 is retrieved. As shown in FIG. 85, septal or external anchor530 and hemostatic plug 1140 b are loaded into the proximal end of firstcatheter sheath 6170 over tether T of anchor assembly 580. As shown inFIGS. 86 and 87, septal anchor 530 and hemostatic plug 1140 b aredeployed against the septum SE in the right ventricle RV, for example,by means of a push catheter. As shown in FIGS. 88 and 89, a lockingmechanism 8810 can be introduced through first catheter sheath 6710 andadvanced against septal anchor 530.

As shown in FIG. 90, the procedure can then be repeated a number oftimes with other sets of anchor assemblies 580 and septal anchors 530being deployed along a pre-selected apposition line. As shown in FIG.91, the sets of anchor assemblies 580 and septal anchors 530 aretightened to produce a cinching effect of the left ventricle LV,reducing its volume. Different sets of anchor assemblies 580 and septalanchors 530 may be alternately tightened. As shown in FIG. 92, a cutter9210 can be advanced adjacent to a locking mechanism 8810 to cut atether T of an anchor assembly 580. As shown in FIG. 93, with thetethers T cut from anchor assemblies 580, the procedure on the heart His complete.

FIG. 94 shows an anchor assembly 580 having an external anchor 530threaded over tether T. FIGS. 95-110 show embodiments of proximal orexternal anchors according to embodiments of the invention. Theseproximal or external anchors may be used with any of the methodsdescribed herein. FIG. 95 shows a proximal anchor 9530. Proximal anchor9530 comprises a support body 9540 enveloped by fabric 9580. Proximalanchor 9530 further comprises an aperture 9535 through which proximalanchor 9530 can be advanced over a tether T of anchor assembly 530.Adjacent to aperture 9535 are a conic lock 9560 on the proximal side ofsupport 9540 and a conic plug 9570 on the distal side of support body9540. FIG. 96 shows a proximal anchor 9630. Proximal anchor 9630comprises a circular support body 9640. Proximal anchor 9630 furthercomprises an aperture 9635 through which proximal anchor 9630 can beadvanced over a tether T of anchor assembly 530. Adjacent to aperture9635 are a lock 9660 on the proximal side of support 9640 and a conicplug 9670 on the distal side of support body 9640. FIG. 97 shows aproximal anchor 9730. Proximal anchor 9730 comprises a rectangularsupport body 9740. Proximal anchor 9730 further comprises an aperture9735 through which proximal anchor 9730 can be advanced over a tether Tof anchor assembly 530. Adjacent to aperture 9735 are a lock 9760 on theproximal side of support 9740 and a conic plug 9770 on the distal sideof support body 9740. FIG. 98 shows a proximal anchor 9830. Proximalanchor 9830 comprises a rectangular support body 9840. Proximal anchor9830 further comprises an aperture 9835 through which proximal anchor9830 can be advanced over a tether T of anchor assembly 530. Adjacent toaperture 9835 are a lock 9860 on the proximal side of support 9840 and aconic plug 9870 on the distal side of support body 9840.

FIGS. 99-102 show a proximal anchor 9930. FIG. 99 shows the proximalside of proximal anchor 9930 while FIG. 100 shows the distal side ofproximal anchor 9930. Proximal anchor 9930 comprises a curved, elongatesupport body 9940 having a plurality of apertures 9935 through whichproximal anchor 9930 can be advanced over tethers T of anchorsassemblies as shown in FIGS. 101 and 102. Although three apertures 9935are shown, other numbers of apertures are conceivable.

FIGS. 103 to 110 show a proximal anchor assembly 10300 and a method ofsecuring proximal anchor assembly 10300 adjacent the heart. Proximalanchor assembly 10300 comprises a middle anchor portion 10310, a firstside anchor portion 10310 a, and a second side anchor portion 10310 b.FIG. 103 shows the proximal side of middle anchor portion 10310. Middleanchor portion 10310 comprises an aperture 10335 through which middleanchor portion 10310 can be threaded over a tether T of an anchorassembly 530 as shown in FIG. 104. A lock 10360 is disposed adjacent toaperture 10335 on the proximal side of middle anchor portion 10310.Middle anchor portion 10310 further comprises a first side adhesiveportion 10390 a and a second side adhesive portion 10390 b. FIG. 103shows the distal side of first side anchor portion 10310 a. First sideanchor portion 10310 a comprises an aperture 10335 through which firstside anchor portion 10310 a can be threaded over a tether T of an anchorassembly 530. A conic plug 10370 is disposed adjacent to aperture 10335on the distal side of first side anchor portion 10390 a. First sideanchor portion 10310 a further comprises an adhesive portion 10391 awhich can adhere to side adhesive portion 10390 a of middle anchorportion 10310 as shown in FIG. 106. FIG. 103 shows the distal side ofsecond side anchor portion 10310 b. Second side anchor portion 10310 bcomprises an aperture 10335 through which second side anchor portion10310 b can be threaded over a tether T of an anchor assembly 530. Aconic plug 10370 is disposed adjacent to aperture 10335 on the distalside of second side anchor portion 10390 b. Second side anchor portionfurther comprises an adhesive portion 10391 b which can adhere to sideadhesive portion 10390 b of middle anchor portion 10310 as shown in FIG.106. To secure proximal anchor assembly 10300, middle anchor portion10310 is first advanced over tether T of an anchor assembly 580 disposedbetween two adjacent anchor assemblies 580 as shown in FIG. 104. Asshown in FIG. 105, first side anchor portion 10310 a and second sideanchor portion 10310 b are then advanced over the tethers T of theadjacent anchor assemblies 580. As seen in FIG. 103, adhesive portion10391 a of first side anchor portion 10310 a adheres with first adhesiveside portion 10390 a of middle anchor portion 10310, adhesive portion10391 b of second side anchor portion 10310 b adheres with secondadhesive side portion 10390 b of middle anchor portion 10310, andtethers T can then be cut.

As shown in FIGS. 107-110, adhering middle anchor portion 10310 withfirst side anchor portion 10310 a and second side anchor portion 10310 bcan be assisted with a first thread 10395 a and a second thread 10395 b.As shown in FIG. 107, first thread 10395 a traverses first side adhesiveportion 10390 a of middle anchor portion 10310 and side adhesive portion10390 a of first side anchor portion 10310 a, and second thread 10395 btraverses second adhesive portion 10390 b of middle anchor portion 10310and side adhesive portion 10390 b of second side anchor portion 10310 b.As shown in FIGS. 108 and 109, first thread 10395 a and second thread10395 b can restrict the rotation of first side anchor portion 10310 aand second side anchor portion 10310 b, respectively, so that adhesiveportion 10391 a of first side anchor portion 10310 a meets firstadhesive side portion 10390 a of middle anchor portion 10310 when firstside anchor portion 10310 a is advanced, and so that adhesive portion10391 a of second side anchor portion 10310 b meets second adhesive sideportion 10390 b of middle anchor portion 10310 when second side anchorportion 10310 b is advanced. As shown in FIG. 110, tethers T, firstthread 10395 a and second thread 10395 b can then be cut.

FIGS. 111, 112A, 112B, 113A, 113B, 114A, 114B, 114C, 115A, 115B, 116A,116B, 117A, 117B, 117C, 118A, 118B, 118C, 118D, 119A, 119B, and 119Cshow additional exemplary embodiments of the distal portion of an anchorassembly according to embodiments of the invention, for example, anchorassembly 580.

FIGS. 111-112B show leading end 11200. Leading end 11200 comprises asuperelastic wire 11205 with a shaped distal end 11250 enveloped by asheath 11210. Superelastic wire 11205 may comprise a Nitinol wire. Asshown by FIG. 111, shaped distal end 11250 can be constrained, forexample, by sheath 1150. When no longer constrained, as in FIGS. 112Aand 112B, shaped distal end 11250 can expand to an expanded, deployedform.

FIGS. 113A to 116B show exemplary embodiments of the distal arm of ananchor having articulated hinges. As shown in FIGS. 113A and 113B, aleading end 11300 comprises an elongate shaft 11310 coupled to a distalarm 11320 through an articulated hinge 11330. FIGS. 114A-114C, show aleading end 11400. Leading end 11400 comprises an elongate shaft 11410coupled to a distal arm 11420 through an articulated hinge 11430. Whenconstrained, for example, by sheath 1150, a portion of distal arm 11420may fit into a recessed portion 11450 of elongate shaft 11410. As shownin FIGS. 115A and 115B, leading end 11400 may further comprise a lockingmechanism 11460 which can be distally advanced to secure leading end11400 in a deployed configuration as shown in FIG. 115B. As shown inFIGS. 116A and 116B, a leading end 11600 may comprise multiple distalarm segments. A central distal arm segment 11620 is coupled to anelongate shaft 11610 through an articulated hinge 11630. Central distalarm segment 11620 can fit into a recessed portion 11650 of elongateshaft 11610 when leading end 11600 is constrained, for example, bysheath 1150 as shown in FIG. 116A. Central distal arm segment 11620 iscoupled to a first side arm segment 11620 a and a second side armsegment 11620 b through articulated hinges 11630. The articulated hinges11630 may be biased so that central arm segment 11620, first side armsegment 11620 a, and second side arm segment 11620 b are each unfurledperpendicular to elongate shaft 11610 when deployed or no longerconstrained, for example, by sheath 1150.

FIGS. 117A-117C show another exemplary anchor assembly leading end11700. Leading end 11700 comprises a leading end or distal tip 11705 anda malecot 11710. Malecot 11710 is expanded to deploy leading end 11700.Malecot 11710 may be expanded, for example, by proximally retractingelongate shaft 11720 which is disposed within malecot 11710 and may beconnected to distal top 11705. Malecot 11710 may be made of a metal, forexample Nitinol, or plastic. Malecot 11710 may be covered or envelopedby a fabric.

FIGS. 118A-118D show another exemplary anchor assembly leading end11800. Leading end 11800 comprises an elongate shaft 11810 coupled to anumbrella 11830. Umbrella 11830 comprises a plurality of bendable spines11832 and fabric 11836 held together with stitching 11838. Umbrella11830 can be constrained into an undeployed from, for example, by sheath1150, as shown in FIGS. 118A and 118B. Bendable spines 11832 of umbrella11830 are biased to deploy umbrella 11830 when no longer constrained asshown in FIGS. 118C and 118D. Fabric 11836 can have a set circumferenceso that fabric 11836 holds spines 11832 rigidly to keep umbrella 11830from prolapsing.

FIGS. 119A-119C show another exemplary anchor assembly leading end11900. Leading end 11900 comprises elongate shaft 11910 coupled to aplurality of segments 11920. Segments 11920 are linked by articulatedhinges 11930. Elongate shaft 11910 is coupled to segments 11920 througha distal segment 11940. When elongate shaft 11910 is proximallyretracted while segments 11920 are held in place, segments 11920 mayflatten relative to one another to place leading end 11900 in anexpanded state.

FIGS. 120A and 120B show an exemplary “nail clipper” cutting mechanismor clipper 12000 which can be used to cut tethers T of anchor assemblies580. Clipper 12000 comprises a distal cap 12010, a tension shaft 12020,snippers 12030, and a compression shaft 12040. As shown in FIG. 120A,distal cap 12010 can be advanced over tether T through an aperture 12015until adjacent to external anchor 530, and tension shaft 12020 andcompression shaft 12040 can be advanced over tether T through a lumen12025 of tension shaft 12020 until adjacent to external anchor 530.Tension shaft 12020 can fit into the lumen of compression shaft 12040.The distal end of tension shaft 12020 is coupled to snippers 12030.Snippers 12030 comprises a pair of jaws which may be adapted to splayoutward. As shown in FIG. 120B, by holding tension shaft 12020 in placeand distally advancing compression shaft 12040, compression ring 12045disposed on the distal end of compression shaft 12040 can press the jawsof snippers 12030 together, cutting tether T.

FIGS. 121A and 121B show an exemplary dual blade cutting mechanism 12100which can be used to cut tethers T of anchor assemblies 580. Cuttingmechanism 12100 comprises a distal cap 12110 coupled to the distal endof a shaft 12120. As shown in FIG. 121A, distal cap 12110 can beadvanced over tether T through an aperture 12115 until adjacent toexternal anchor 530, and shaft 12120 can be advanced over tether Tthrough a lumen 12125 of shaft 12120. Distal cap 12110 comprises blades12113 which are oriented toward tether T and are disposed proximal ofstops 12117. Shaft 12120 comprises distal arms 12127 facing distallytoward blades 12113. As shown in FIG. 121B, when distal cap 12110 isretracted proximally, distal arms 12127 of shaft 12120 can push blades12113 toward tether T and cut tether T. Stops 12117 can prevent blades12113 from being pushed too distally.

FIGS. 122A-122C show an exemplary single blade cutting mechanism 12200which can be used to cut tethers T of anchor assemblies 580. Cuttingmechanism 12200 comprises a shaft 12220 having a lumen 12225 and adistal aperture 12215 through which cutting mechanism 12200 can beadvanced over tether T. Disposed within lumen 12225 are a blade 12213coupled to an activation wire 12211. Blade 12213 is oriented toward thetether T. As shown in FIGS. 122B and 122C, activation wire 12211 can beretracted, thus actuating blade 12213 toward tether T and cutting tetherT.

FIGS. 123A-123D show an exemplary catheter director 12310 according toembodiments of the invention. As shown in FIG. 123D, catheter director12310 may be used to direct second catheter sheath 7010 toward region6910 of the septum SE. Catheter director 12310 comprises a main body12311 coupled to a distal body 12314 through an elongate portion 12313and an articulated hinge 12315. A flexible sheath 12320 can be disposedwithin main body 12311 and distal body 12314. Distal body 12314 iscoupled to the distal end of sheath 12320. As shown in FIGS. 123A-123C,flexible sheath 12320 can be advanced distally. Distal body 12314 holdsthe distal end of sheath 12320 in place as it is advanced but allowsdistal end of sheath 12320 to change orientations. As sheath 12320 isadvanced distally, some “slack” is added to sheath 12320 between pivotor hinge 12315 and main body 12311 and the direction to which aperture12325 of flexible sheath 12320 faces is oriented laterally, in acontrolled manner, so that this mechanism causes sheath 7010 to curvewithin the ventrical away from the septum and then back toward theseptum.

FIGS. 124A-124E show an exemplary second catheter sheath 12400 accordingto embodiments of the invention. Second catheter sheath 12400 may beused similarly to how second catheter sheath 7010 is used as describedabove. FIG. 124A shows second catheter 12400 positioned in heart H.Second catheter sheath 12400 comprises multiple lumens 12435 as shown inthe cross-section of second catheter sheath 12400 shown by FIG. 124B.Although three lumens 12435 are shown, any number of lumens 12435 can beenvisioned. As shown in FIGS. 124C and 124E, lumens 12435 lead toapertures 12436. Apertures 12436 are spaced at set distanced from eachother and are predictably proximal from the apex of second cathetersheath 12400. One of the lumens 12435 can be used to direct a guidewireand/or dilator while the other two lumens may be used to stabilize thecatheter, for example, with suction. After an anchor assembly 580 ispositioned in the heart as desired, another of the lumens 12435 can beused to direct the guidewire and/or dilator while other two lumens canbe used to stabilize the catheter, for example, with suction. After asecond anchor assembly 580 is positioned in the heart, the remaininglumen 12435 can be used to direct the guidewire and/or dilator while theother two lumens can be used to stabilize the catheter, for example,with suction. Thus, anchor assemblies 580 can be positioned in the heartat set distances from each other and in predictable positions.

FIGS. 125A-125C show an exemplary second catheter sheath 12510 accordingto embodiments of the invention. Second catheter sheath 12510 may beused similarly to how second catheter sheaths 7010 and 12400 are used asdescribed above. FIG. 125A shows an exemplary second catheter sheath12510 positioned against septum SE. FIG. 125B shows the cross section ofsecond catheter sheath 12510 which comprises a device lumen 12525 and asuction lumen 12515. A guidewire or dilator may be advanced throughdevice lumen 12525 while suction may be affected through suction lumen12515 to stabilize second catheter sheath 12510. FIG. 125C shows aperspective view of second catheter sheath 12510.

Other exemplary second catheter sheaths can be envisioned. For example,FIG. 126 shows a second catheter sheath 12510 comprising a device lumen12625 and a plurality of suction lumens 12615. A guidewire or dilatormay be advanced through device lumen 12625 while suction may be affectedthrough suction lumens 12615 to stabilize second catheter sheath 12510.Suction lumens 12615 are arranged concentrically about device lumen12625.

While exemplary embodiments have been described in some detail, it isunderstood that various modifications and changes could readily be madewithout departing from the spirit of the invention, which is solelylimited by the appended claims.

What is claimed is:
 1. A system for treating a heart, the heart having achamber bordered by a wall, the system comprising: a first catheterhaving a lumen that extends along a longitudinal length of the firstcatheter; a guidewire that is insertable through a perforation in thewall of the heart; a second catheter that is separate from the firstcatheter, the second catheter being insertable over the guidewirethrough the wall of the heart; a balloon that is coupled with a distalend of the second catheter, the balloon being insertable through thewall in a deflated state and the balloon being inflatable so that uponproximal retraction of the second catheter relative to the wall, anaxially oriented outer surface of the balloon engages with the wall; ananchor that is engageable with the wall; and a tension member that iscoupled with the anchor so that the anchor is tensionable, via thetension member, to urge the wall toward another wall positioned on anopposite side of the chamber; wherein the second catheter includes afluid port that is fluidly coupled with the balloon such that a fluid isdeliverable through the fluid port to the balloon to inflate theballoon.
 2. The system of claim 1, wherein the fluid port is configuredso that the fluid is retractable from the balloon and through the fluidport to deflate the balloon.
 3. The system of claim 2, wherein the fluidthat is delivered to the balloon or retracted therefrom consists ofsaline.
 4. The system of claim 1, wherein the fluid port is fluidlycoupled to the balloon via a radially extending port between the balloonand the fluid port.
 5. The system of claim 1, wherein the ballooncomprises a first balloon component and a second balloon component thatis positioned distally of the first balloon component.
 6. The system ofclaim 5, wherein the first balloon component and the second ballooncomponent have different outer diameters when inflated.
 7. The system ofclaim 5, wherein the first balloon component and the second ballooncomponent are separated from one another by a gap.
 8. The system ofclaim 5, wherein the second balloon component is configured to dilatethe perforation in the wall.
 9. The system of claim 1, wherein theballoon is a second balloon and wherein the system includes a firstballoon coupled with the first catheter.
 10. The system of claim 9,wherein the first balloon is inflatable independently of the secondballoon and the second balloon is inflatable independently of the firstballoon.
 11. The system of claim 9, wherein the first catheter and firstballoon are moveable independently of the second catheter and secondballoon.
 12. The system of claim 1, wherein the system includes a plughaving a tail structure that is configured to fit into the perforationin the wall to block or seal the perforation in the wall.
 13. A methodof treating a heart comprising: advancing a first catheter through aperforation in a first wall of the heart; inserting a guidewire throughthe perforation in the first wall of the heart so that a distal end ofthe guidewire is positioned in a chamber of the heart; advancing asecond catheter over the guidewire toward the first wall of the heart;inserting a balloon through the first wall of the heart with the balloonin a deflated state, the balloon being insertable through the first wallso that the balloon is positioned distally of the first wall; inflatingthe balloon by delivering fluid through a fluid port to the balloon;engaging the balloon with the first wall of the heart; and retractingthe balloon proximally relative to the first wall to urge the first walltoward a second wall of the heart.
 14. The method of claim 13, furthercomprising retracting the fluid from the balloon to deflate the balloon.15. The method of claim 13, wherein the balloon is coupled with a distalend of the second catheter, and wherein the method further comprisesretracting the first catheter through a lumen of the second catheter,and through the perforation in the first wall, upon inflation of theballoon of the balloon and engagement of the balloon with the firstwall.
 16. The method of claim 13, wherein the balloon is a secondballoon that is coupled with the second catheter, and wherein a firstballoon is coupled with the first catheter.
 17. The method of claim 16,wherein the method further comprises inflating the first balloonindependently of the second balloon, or the method further comprisesmoving the first catheter and first balloon independently of the secondcatheter and second balloon.
 18. The method of claim 13, wherein theballoon comprises a first balloon component and a second ballooncomponent that is positioned distally of the first balloon component.19. The method of claim 13, further comprising inserting a plug having atail structure into the perforation in the first wall to block or sealthe perforation in the first wall.